Impact of structured educational interventions on the prevention of pressure ulcers in immobile orthopedic patients in India: A pragmatic randomized controlled trial

Background: Pressure ulcer (PU) is one of the common, neglected and avoidable complications among bedridden patients. Despite the potential to reduce PU incidence, the evidence on the effect of patient/caregiver education is low. This pragmatic randomized controlled trial (CTRI/2011/07/001862) compared the impact of two structured educational interventions to patients and caregivers on prevention of PU in immobile orthopaedic patients. Methodology: Ninety-two orthopedically immobile patients (Braden score ≤12 or stage I PU) and their caregivers were (block) randomized into two equal groups. One group was offered Prevention Package 1 (PP1), i.e., self-instruction manual (SIM), one to one training and counselling on PU care practices. The second group (PP2) was given SIM only. Patients were followed equally at the hospital and home after discharge. Intention to treat analysis was conducted. Results: The cumulative incidence of PU was 8.7% in PP1 and 21.7% in PP2 for the entire study period. PU incidence rate in PP1 and PP2 was 0.9 and 2.41 per 1000 person-days, respectively. Incidence rate ratio was 2.67 (95% CI: 0.89, 8.02, p-0.04). The Kaplan-Meier survival curves of PP1 and PP2 were statistically significantly different (p-0.043). PP1 also showed statistically significant improvement in knowledge on the prevention and management of PU compared to PP2 at post-intervention (p